The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.
美国食品药品管理局今天批准Victrelis (boceprevir)用于成人慢性丙型肝炎治疗。Victrelis适用于仍具有部分肝功能，以往未接受过丙型肝炎治疗或者治疗失败的患者。FDA批准Victrelis与聚乙二醇干扰素α以及病毒唑联合使用。

The safety and effectiveness of Victrelis was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response (i.e., the hepatitis C virus was no longer detected in the blood 24 weeks after stopping treatment), compared to pegylated interferon and ribavirin alone, the current standard of care.

Victrelis的安全性和有效性已通过2项入选1500位受试者的3期临床试验证实。在这两项试验中，均有2/3的受试者接受了Victrelis联合聚乙二醇干扰素α和病毒唑治疗，和接受目前标准治疗即聚乙二醇干扰素α联合病毒唑的受试者相比，这组受试者的持续病毒学应答（即，治疗停止后24W受试者血液中未检出丙型肝炎病毒）明显增加。

When a person sustains a virologic response after completing treatment, this suggests that HCV infection has been cured.
当受试者完成治疗后病毒学应答仍在持续，说明丙型肝炎病毒感染已获治愈。

Sustained virologic response can result in decreased cirrhosis and complications of liver disease, decreased rates of liver cancer (hepatocelluar carcinoma), and decreased mortality.
持续病毒学应答可以降低肝硬化和肝病并发症的发生，降低肝癌（肝细胞性癌）和死亡的发生率。
“Victrelis is an important new advance for patients with hepatitis C,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy.”
FDA药品评价与研究中心抗菌产品办公室主任Edward Cox博士说：“对于丙型肝炎患者来说，Victrelis是一个重要进展，为这种严重疾病提供了一种有效的治疗方法，相比于现有的治疗方法具有更高的治愈率。“

According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.

根据美国疾病控制预防中心的数据，美国有320万人罹患丙型肝炎，丙型肝炎病毒可以引起肝脏炎症反应进一步导致肝功能下降或肝功能衰竭。

Most people with hepatitis have no symptoms of the disease until liver damage occurs, which may take several years.
大多数肝炎患者直到肝脏受到损害时才会出现症状，这个过程往往需要几年才会出现。

Most liver transplants performed in the United States are due to progressive liver disease caused by hepatitis C virus infection. After the initial infection with hepatitis C virus (HCV), most people develop chronic hepatitis C. Some will develop cirrhosis of the liver over many years. Cirrhosis can lead to liver damage with complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in abdomen, infections, or liver cancer.

大多数美国肝脏移植病例都源于丙型肝炎病毒导致的肝脏疾病进展。初次感染丙型肝炎病毒后，大多数的患者都会发展成为丙型肝炎，有一些经过数年后发展成为肝硬化。肝硬化可以导致肝脏损害，常伴有出血、黄疸(眼睛或皮肤黄染)、腹水、感染、或肝癌。

People can get the hepatitis C virus in a number of ways, including: exposure to blood that is infected with the virus; being born to a mother with HCV; sharing a needle; having sex with an infected person; sharing personal items such as a razor, toothbrush with someone who is infected with the virus, or from unsterilized tattoo or piercing tools.
丙型肝炎病毒有多种感染途径，包括：血液传播、母婴传播、共用针头、性行为、共用牙刷和剃须刀等个人物品以及使用无消毒的纹身及穿刺工具等。

Victrelis is a pill taken three times a day with food. The therapy is part of a class of drugs referred to as protease inhibitors, which work by binding to the virus and preventing it from multiplying.
Victrelis丸剂的用法为每日三次，进餐时服用。这种治疗药物属于蛋白酶抑制剂的一种，通过与病毒结合组织其复制行为发挥作用。

The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin include fatigue, low red blood cell count (anemia), nausea, headache and taste distortion (dysgeusia).
Victrelis和聚乙二醇干扰素α以及病毒唑治联合使用中报道最常见的副作用包括疲劳、红细胞数量减少（贫血）以及味觉障碍。

Victrelis is marketed by Whitehouse Station, N.J.-based Merck.
Victrelis由总部位于纽约白屋站的默克公司销售。

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